Surgical instrument with bended shaft

ABSTRACT

A surgical bone cutting device, including a handle configured to facilitate operation and control of said device by an operator, and an elongated hollow member extending from the handle, the hollow member having a proximal end and a distal end; wherein the hollow member includes an opening at the distal end thereof and a rotatable cutting element extending through the opening, and wherein the hollow member includes a first bend at the proximal end thereof, such that the part of the hollow member distal to the proximal bend is offset a central axis of the hand.

RELATED APPLICATIONS

This application is a National Phase of PCT Patent Application No.PCT/IL2018/050046 having International filing date of Jan. 11, 2018,which claims the benefit of priority of U.S. Provisional Application No.62/445,051 filed on Jan. 11, 2017. The contents of the aboveapplications are all incorporated by reference as if fully set forthherein in their entirety.

TECHNICAL FIELD

The present disclosure generally relates to the field of surgical toolsfor removal of tissue, preferably bone tissue.

BACKGROUND

Excess body tissue can lead to pathological conditions and pain,especially when the excess tissue affects the nervous system. One commonproblem is Spinal Stenosis, Degenerative Disc Disease and other spinepathologies where excess bone tissue affects the spinal cord and relatedneural elements. Two of the most prominent conditions associated withnarrowing (stenosis) of the spinal or nerve root canal are: excess bonegrowth into the spinal or nerve root canal resulting in a neurologicaldeficit, and bulging or herniated disc.

Spinal Stenosis and Degenerative Disc Disease is typically treated byremoving all or part of the vertebral body or bone spurs pushing intothe neural elements, usually as a way to decompress the spinal nerves toalleviate or treat the neurological deficit. As to a herniated disc, itis commonly treated with a surgical procedure called discectomy, duringwhich herniated disc material that presses against the nerve root orspinal cord is removed.

The tissue intended for removal is often hard tissue, such as bone,which requires special physical properties from the cutting or grindingmember. Moreover, the undesired tissue is typically located in positionsthat are difficult to reach and the surgical procedures requireselective removal of tissue while avoiding causing harm to surroundingtissue, e.g. dural sack and/or dural nerves that can be fragile orvulnerable to damage.

There is thus a need in the art for surgical instruments that provideselective cutting/resection/removal of hard-to-access tissue, whilemitigating the harm of damaging surrounding tissue.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods which aremeant to be exemplary and illustrative, not limiting in scope. Invarious embodiments, one or more of the above-described problems havebeen reduced or eliminated, while other embodiments are directed toother advantages or improvements.

According to some embodiments, there is provided a surgical deviceincluding a handle configured to facilitate operation and control of thedevice by an operator, an elongated hollow member extending from thehandle, the hollow member having a proximal end and a distal end;wherein the distal end of the hollow member includes an opening, atorque transferring element/assembly, configured to be placed within theelongated hollow member, and a rotatable cutting element attached tosaid torque transferring element/assembly and extending through orpositioned at the opening; wherein the proximal end of the hollow memberincludes at least one proximal bend configured to ensure that the partof the hollow member, which is distal to the proximal bend, is offset acentral axis of the handle, wherein said torque transferringelement/assembly is configured to affect rotary motion of the rotatablecutting element.

According to some embodiments, the torque transferring element/assemblyis configured to facilitate rotational speed of at least 15,000 RPM, atleast 20,000 RPM, at least 30,000 RPM, at least 40,000 RPM, or at least50,000 RPM and a torque of at least 4 Ncm, while being bent and/or keptin a bent configuration. According to some embodiments, the torquetransferring element/assembly is configured to facilitate abidirectional rotational speed of at least 15,000 RPM, at least 20,000RPM, at least 30,000 RPM, at least 40,000 RPM, or at least 50,000 RPMand a torque of at least 4 Ncm.

In surgical procedures for removal of excess tissue, it is of highimportance to perform selective removal only of the undesired tissue,while mitigating any removal or damage of surrounding tissue.

Advantageously, the offset configuration of the shaft relative to thehandle, caused by the proximal bend, is configured to ensure that thedistal end of the shaft, carrying the cutter, is not concealed by thesurgeon's hand, by the handle, by the tube through which it isdelivered, such as, but not limited to, an endoscope, and/or whenutilizing surgical microscopes. Better visualization of the work area isthus assured.

According to some embodiments, the shaft may include an additionalproximal bend. Such double bending allows obtaining a configuration inwhich part of the hollow member downstream the proximal bends issubstantially parallel to the central axis of the handle.

Additionally or alternatively, the device may include one or more medialbends positioned between the proximal and distal ends of the hollowelongated member, such as, but not limited to, around halfway the lengthof the hollow elongated member. Advantageously, such medial bends mayensure an unhindered line of site when utilizing the device inrobotic/robot assisted surgeries.

As a further advantage, the torque transferring element/assembly mayinclude one or more support structures configured to prevent helixing ofthe torque transferring element/assembly. This is of particularimportance due to need for torque delivery over bent configurations andat high rotational speed.

An existing solution for torque delivery utilizes a long and hardstainless-steel wire (1-1.5 mm diameter) that, while allowing bending ofthe shaft (hollow elongated member), at high speed (60K RPM) and torquerequires a large bending radius, typically more than 100 mm, which istoo big for the human anatomy.

Another solution for torque delivery applies a torque element made ofnumerous strips made by cutting (e.g. by cutting a tube made of threelayers with various direction (counter clockwise and clockwise)intermittently, with a fitted guide. Such a solution, while allowing abending radius of 30-40 mm, cannot be operated at high-speed, such asabove to 12K RPM.

Furthermore, both solutions incur high friction between the rotatabletorque transferring element and the guiding shaft, which friction oftencauses overheating and mechanical failure of the torque transferringelement.

According to some embodiments, a shaft with a single proximal bend maybe of particular advantage when utilizing surgical microscopes and/orendoscopes that have short focal length, and that preferably would belocated parallel to the shaft and close to the surgical site, this,since the handle is prevented from interfering with the illuminationpath and the line of sight of the endoscope.

According to some embodiments, a shaft with two proximal bends may beadvantageous for maintaining line of sight in particular for opensurgeries and/or endoscopic procedures.

According to some embodiments, the hollow member may further include adistal bend configured to allow access to difficult to reach targettissue/hidden anatomies, such as, but not limited to, between adjacentvertebrae and/or sites within/near the spinal canal.

That is, whereas the distal bend is configured to enable access andmaneuverability of the device at hidden anatomies, e.g. between orunderneath vertebral discs, the proximal bend(s) is/are configured toenable an unhindered line of site of the device's distal tip, regardlessof it having a distal bend or not.

According to some embodiments, there is provided a surgical device,including a handle configured to facilitate operation and control of thedevice by an operator, an elongated hollow member extending from thehandle, the hollow member having a proximal end and a distal end;wherein the distal end of the hollow member includes an opening, atorque transferring element/assembly, configured to be placed within theelongated hollow member, and a rotatable cutting element attached tosaid torque transferring element/assembly and extending through orpositioned at the opening; wherein the proximal end of the hollow memberincludes at least one proximal bend configured to ensure that the partof the hollow member, which is distal to the proximal bend, is offset acentral axis of the handle, wherein said torque transferringelement/assembly is configured to affect rotary motion of the rotatablecutting element.

According to some embodiments, the torque transferring element/assemblyis configured to facilitate (optionally bi-directional) rotational speedof at least 40,000 RPM and a torque of at least 4 Ncm.

According to some embodiments, the bend enables the operator to maintainvisibility of the cutting tip when holding the handle and or whenutilizing endoscopes or surgical microscopes.

According to some embodiments, the first proximal bend comprises abending angle of up to 90 degrees relative to the central axis of thehandle. According to some embodiments, the first proximal bend comprisesa bending angle of 20-60 degrees relative to the central axis of thehandle. According to some embodiments, the first proximal bend comprisesa bending radius of less than 20 mm.

According to some embodiments, the device further comprises a secondproximal bend. According to some embodiments, wherein part of the hollowmember distal to the first and second proximal bends is substantiallyparallel to the central axis of the handle, as used herein, the term“substantially” may refer to +/−10 degrees or +/−5 relative to thecentral axis of the handle.

According to some embodiments, the second proximal bend comprises abending angle of up to 90 degrees relative to the central axis of thehandle. According to some embodiments, the second proximal bendcomprises a bending angle of 20-60 degrees relative to the central axisof the handle. According to some embodiments, the second proximal bendcomprises a bending radius of less than 20 mm.

According to some embodiments, the device further includes a bend at adistal end thereof. According to some embodiments, the distance betweenthe distal bend and the opening is less than 20 mm.

According to some embodiments, the distal bend comprises a bending angleof up to 90 degrees relative to part of the hollow member distal to thefirst or second proximal bend. According to some embodiments, the distalbend comprises a bending angle of 0-60 degrees relative to part of thehollow member distal to the first or second proximal bend. According tosome embodiments, the distal bend comprises a bending radius of lessthan 10 mm relative to part of the hollow member distal to the first orsecond proximal bend.

According to some embodiments, the distal end is offset to the centralaxis of the handle. According to some embodiments, the distal end isparallel to the central axis of the handle.

According to some embodiments, the device further includes a torquetransferring element configured to be placed within the elongated hollowmember and to affect rotary motion of the rotatable cutting element, thetorque transferring element comprising a core and at least one outerlayer, the core comprising a bendable multi-stranded wire.

According to some embodiments, the torque transferring assembly furthercomprises a support structure configured to prevent helixing thereof.

According to some embodiments, the support structure comprises one ormore rigid elements configured to define rigid and bendable sectionsalong the torque transferring assembly/element, wherein sections of thetorque transferring assembly/element, devoid of the rigid elements, arebendable. According to some embodiments, the one or more rigid elementscomprise one or more tubular elements crimped over spaced apart sectionsof the torque transferring elongated members located in non-bendportions of the hollow elongated member.

Additionally or alternatively, the support structure comprises one ormore bearings. According to some embodiments, the one or more bearingsare configured to be positioned along a part of the torque transferringelongated member located in bend portions of the hollow elongatedmember.

According to some embodiments, the device further includes a torquetransferring assembly configured to be placed within the elongatedhollow member and to affect rotary motion of the rotatable cuttingelement. The torque transferring assembly includes a tube having torquetransferring elements at its proximal and distal ends, wherein thetorque transferring elements comprise a bendable core and at least oneouter layer. According to some embodiments, the core is comprising amulti-stranded wire.

According to some embodiments, the device further includes a rotaryactuator, placed within the handle configured to induce rotation motionto the torque transferring element/assembly.

According to some embodiments, the device further includes acontrol-interface configured to facilitate operation control over arotation speed of said rotary actuator, and/or of said torquetransferring element/assembly.

According to some embodiments, the device is a surgical drill.

According to some embodiments, the device further includes a thirdproximal bend.

According to some embodiments, there is provided a torque transferringassembly comprising: a torque transferring elongated member comprising acore and at least one outer layer, said core comprising a multi-strandedwire; a rotatable cutting element attached to a distal end and of saidtorque transferring elongated member; and a support structure configuredto prevent helixing of said torque transferring elongated member whenbent; wherein said torque transferring element/assembly is configured tofacilitate rotary motion of the rotatable cutting element at least15,000 RPM, at least 20,000 RPM, at least 40,000 and a torque of atleast 4 Ncm.

According to some embodiments, the support structure comprises one ormore rigid elements configured to define rigid and bendable sectionsalong the torque transferring elongated member, wherein sections of thetorque transferring elongated member, devoid of the rigid elements, arebendable.

According to some embodiments, the support structure comprises one ormore tubular elements crimped over sections of said torque transferringelongated member.

Additionally or alternatively, the support structure comprises one ormore bearings. According to some embodiments, the one or more bearingsare configured to be positioned along a part of the torque transferringelongated member devoid of rigid elements so as to define an apex of thetorque transferring elongated member when bent.

According to some embodiments, the torque transferring element/assemblyis configured to facilitate rotary motion of the rotatable cuttingelement at least 40,000 RPM, and a torque of at least 4 Ncm.

Certain embodiments of the present disclosure may include some, all, ornone of the above advantages. One or more technical advantages may bereadily apparent to those skilled in the art from the figures,descriptions and claims included herein. Moreover, while specificadvantages have been enumerated above, various embodiments may includeall, some or none of the enumerated advantages.

In addition to the exemplary aspects and embodiments described above,further aspects and embodiments will become apparent by reference to thefigures and by study of the following detailed descriptions.

BRIEF DESCRIPTION OF THE DRAWINGS

Examples illustrative of embodiments are described below with referenceto figures attached hereto. In the figures, identical structures,elements or parts that appear in more than one figure are generallylabeled with a same numeral in all the figures in which they appear.Alternatively, elements or parts that appear in more than one figure maybe labeled with different numerals in the different figures in whichthey appear. Dimensions of components and features shown in the figuresare generally chosen for convenience and clarity of presentation and arenot necessarily shown in scale. The figures are listed below.

FIG. 1A schematically illustrates a side view of a device fir hardtissue removal with a hollow elongated member with a proximal bend, adistal bend and a torque transferring assembly with rigid sections,according to some embodiments;

FIG. 1B is an enlarged view of a proximal end of the hollow elongatedmember of FIG. 1A, according to some embodiments;

FIG. 1C is an enlarged view of a distal end of the hollow elongatedmember of FIG. 1A, according to some embodiments;

FIG. 2A schematically illustrates a side view of a device for hardtissue removal with a hollow elongated member with a proximal bend, adistal bend and a torque transferring assembly with rigid sections and abearing element, according to some embodiments;

FIG. 2B is an enlarged view of a proximal end of the hollow elongatedmember of FIG. 2A, according to some embodiments;

FIG. 3A schematically illustrates a side view of a device for hardtissue removal with a hollow elongated member with two proximal bends,according to some embodiments;

FIG. 3B is an enlarged view of a proximal end of the hollow elongatedmember of FIG. 3A, according to some embodiments;

FIG. 4 schematically illustrates a side view of a device for hard tissueremoval with a hollow elongated member with medial bends, according tosome embodiments;

FIG. 5A is an enlarged view of a distal end of a hollow elongated memberdevoid of a distal bend, according to some embodiments;

FIG. 5B is an enlarged view of a distal end of a hollow elongated memberhaving a distal bend and a shield opposite the apex of the distal bend,according to some embodiments;

FIG. 5C is an enlarged view of a distal end of a hollow elongated memberhaving a distal bend and a front shield opposite the apex of the distalbend, according to some embodiments;

FIG. 5D is an enlarged view of a distal end of a hollow elongated memberhaving a distal bend and a shield coextensive with the apex of thedistal bend, according to some embodiments;

FIG. 5E is an enlarged view of a distal end of a hollow elongated memberhaving a distal bend and a front shield coextensive with the apex of thedistal bend, according to some embodiments;

FIG. 6 schematically illustrates the device of FIG. 1A in use forinterverbal disc tissue removal, according to some embodiments;

FIG. 7A schematically illustrates a front-perspective view of the deviceof FIG. 1A connected to an imaging plate with navigation elements,according to some embodiments;

FIG. 7B schematically illustrates a back-perspective view of the deviceof FIG. 1A connected to an imaging plate with navigation elements,according to some embodiments;

DETAILED DESCRIPTION

In the following description, various aspects of the disclosure will bedescribed. For the purpose of explanation, specific configurations anddetails are set forth in order to provide a thorough understanding ofthe different aspects of the disclosure. However, it will also beapparent to one skilled in the art that the disclosure may be practicedwithout specific details being presented herein. Furthermore, well-knownfeatures may be omitted or simplified in order not to obscure thedisclosure.

According to some embodiments, there is provided a surgical deviceincluding an elongated hollow member extending having a proximal end anda distal end; wherein the distal end of the hollow member includes anopening, a torque transferring element/assembly, configured to be placedwithin the elongated hollow member, and a rotatable cutting elementattached to said torque transferring element/assembly and extendingthrough or positioned at the opening; wherein the proximal end of thehollow member includes at least one proximal bend configured to ensurethat the part of the hollow member, which is distal to the proximalbend, is offset a central axis of part of the hollow member proximal tothe proximal bend, wherein said torque transferring element/assembly isconfigured to affect rotary motion of the rotatable cutting element.

According to some embodiments, the device further includes a handleconfigured to facilitate operation and control of the device by anoperator. According to some embodiments, the proximal bend of the hollowmember is configured to ensure that the handle does not interfere with asurgeon's line of site to the cutting element.

According to some embodiments, the torque transferring element/assemblyis configured to facilitate rotational speed of at least 15,000 RPM, atleast 20,000 RPM, at least 25,000 RPM, at least 30,000 RPM or 40,000RPM, and a torque of at least 4 Ncm. Each possibility is a separateembodiment.

According to some embodiments, the torque transferring element/assemblymay include one or more support structures configured to preventhelixing, pig-tailing and or looping thereof.

According to some embodiments, the terra “helixing”, “pig-tailing”,“looping”, “coiling” and “torqueing” may be used interchangeably and mayrefer to the inherent tendency of the torque transfer element to form ahelix-like shape when a torque is being applied thereto. Helixingespecially tends to cause failure and even tearing of the torquetransfer element and/or layers thereof. While a sheering stress isassociated with a sheering strain, i.e. rotation angle, the helixingphenomena might force that strain to be dispersed over a short length ofthe flexible torque transfer element, thus generating great localstresses which lead to a quick failure. Helixing is the most commoncause fir failure in flexible torque transferring elements.

According to some embodiments, the device is configured for bone andsoft tissue removal. According to some embodiments, the device isconfigured to perform minimally invasive tissue resection, cutting,grinding and/or drilling. Each possibility is a separate embodiment. Asused herein, the terms “tissue removal”, “tissue cutting”, “tissuegrinding”, “abrasive tissue cutting/grinding” may be interchangeable andinclude tissue reshaping, removal of excess tissue and/or tissuesharpening, or the like.

According to some embodiments, the device is configured to facilitateremoval of hard and soft tissue from target locations/sites adjacentvertebrae and/or sites within/near the spinal canal.

According to some embodiments, the device is configured to treat and/orameliorate spinal indications. According to some embodiments, the spinalindication is selected from: lumbar, thoracic, sacrum or cervical spinalstenosis, herniated disc, and/or bulged disc. According to someembodiments, the spinal indication is lumbar, thoracic, sacrum orcervical spinal stenosis. According to some embodiments, the tissue isan intervertebral disc tissue or bone tissue.

According to some embodiments, the device may advantageously facilitateminimal invasive treatment of lumbar, thoracic, sacrum or cervicalspinal stenosis without removal of vertebrae or with minimal removal ofthe vertebrae. This as opposed to the common treatments in whichvertebra and excess bone tissue is removed, and which necessitate fusionof adjacent vertebras in order to prevent spinal instability, and whichare associated with long recuperation and pain. According to someembodiments, the instruments are configured for safe insertion betweentwo adjacent vertebrae, allowing removal of excess osteophytes, bonesand disc tissue. According to some embodiments, the device is configuredfor use in operations that include removal of soft tissue, such as adisc tissue, allowing treating a herniated or bulged disc. According tosome embodiments, the device is configured for use in operations thatinclude preparation of vertebras walls for fusion.

According to some embodiments, the device is configured for cuttingtissue, such as disc tissue, by juxtaposing the device to the targetlocation and introducing/contacting the cutter with the tissue to becut. Advantageously, the device, according to some embodiments, mayenable conducting procedures, such as disc removal, without therequirement of removing pieces of bone (such as the lamina) from theaffected vertebra, thus allowing minimally invasive procedures fortreating a herniated disc and contributing to higher success rates andfaster recovery of the patients.

According to some embodiments, the device is delivered to the discutilizing an accessory tool or instrument such as an endoscope orsurgical microscope, a cannulated instrument configured to allowinserting the device through the disc without harming said disc, orsimilar procedures.

According to some embodiments, the dimensions of the device or any partthereof, are designed and shaped to facilitate a “low profile” safeinsertion of the device in between two adjacent vertebrae and provideaccess to material present underneath vertebrae, which removal isdesired.

According to some embodiments, the torque transferring element may be acable. According to some embodiments, the torque transferring elementmay be a wire or a wire-like elongated bendable member. According tosome embodiments, the torque transferring assembly may extend along theentire/majority of the length of the elongated hollow member. Accordingto some embodiments, the torque transferring element may be a cableextending along the entire/majority of the length of the elongatedhollow member.

As used herein the term “entire” may refer to 80%-100%, such as at least80%, at least 85%, at least 90%, at least 95% or at least 98% of thelength of the elongated hollow member. Each possibility is a separateembodiment. As used herein the term “majority” may refer to 55%-80% ofthe length of the elongated hollow member, such as about 55%, about 60%,about 65%, about 70%, about 75% or about 80%. Each possibility is aseparate embodiment.

According to some embodiments, the torque transferring assembly'ssupport structure may include rigid element(s)/section(s). According tosome embodiments, the rigid element(s)/section(s) may extend alongessentially the entire non-bent portions of the torque transferringassembly's or a majority thereof. According to some embodiments, theportion of the torque transferring elementpositioned/extending/ranging/encompassing the proximal bend (or otherbends) may be devoid of rigid elements. According to some embodiments,the rigid element/section may overlay part of the one or more torquetransferring elements. According to some embodiments, the rigidelement(s)/section(s) may overlay the non-bent part(s) of the one ormore torque transferring elements, or the majority of the non-bentpart(s). As a non-limiting example, the rigid element(s)/section(s) mayoverlay the non-bent portion of a single torque transferring element,extending essentially along the entire length of the hollow elongatedmember. According to some embodiments, the rigid element(s)/section(s)may be tube elements crimped over or otherwise attached/affixed to theone or more torque transferring elements (non-bent portions). Accordingto some embodiments, the rigid sections may include or be made fromstainless steel (304, 316, 420) and/or polymeric materials (e.g. Nylon,HDPE, PTFE). According to some embodiments, the rigid elements may beshaped as tubes with an inner diameter of about 1 mm and outer diameterof about 1.5-3 mm (e.g. 1.46 mm or 2.5 mm) and a wall thickness about0-2-0.3 mm—e.g. 0.23 mm. Alternatively, the rigid elements may be squareshaped. As a non-limiting example, the rigid elements may be squareshaped and have internal dimensions of 1 mm×1 mm and outer dimensions of1.46 mm×1.46 mm and an internal area of 1 mm² and outer area of 2.13mm².

As used herein, the terms “non-bent part” or “non-bent portions” of thetorque transferring assembly may refer to the part of the torquetransferring assembly running through the essentially straightportion(s) of the hollow elongated member or a majority of theessentially straight portion(s), e.g. at least 95%, at least 90% or atleast 85% of the essentially straight portion(s).

According to some embodiments, the rigid element/section mayinterconnect between two torque transferring elements. According to someembodiments, the rigid element(s)/section(s) may be hollow. According tosome embodiments, the rigid element(s)/section(s) may be non-hollow.

According to some embodiments, the torque transferring assembly mayinclude at least two torque transferring elements, positioned within apart of the hollow member, including bends. According to someembodiments, a first torque transferring element may be positionedwithin the part of the hollow member, including the proximal bend.According to some embodiments, a second torque transferring element maybe positioned within the part of the hollow member, including the distalbend. According to some embodiments, the second torque transferringelement of the torque transferring assembly may be positioned within thetip section of the hollow member.

According to some embodiments, the torque transferring element(s) mayinclude a core and at least one outer layer, the core comprising abendable multi-stranded wire. According to some embodiments, themulti-stranded wire of the core may include three strands. According tosome embodiments, the multi-stranded wire of the core may include sevenstrands. According to some embodiments, the multi-stranded wire of thecore may include nineteen strands. According to some embodiments, themulti-stranded wire of the core may include more than nineteen strands.According to some embodiments, the strands of the multi-stranded wiremay be braided, twisted, interlaced or coiled. Each possibility is aseparate embodiment.

According to some embodiments, the rigid element(s)/section(s) isconfigured to extend along at least a portion of the part of theelongated hollow member extending between the distal-most of theproximal bends and the proximal-most of the distal bends.

Additionally or alternatively, the torque transferring assembly'ssupport structure may include a bearing such as a ball bearing, afriction bearing or any other suitable type of rotary support elementconfigured to reduce friction between the torque transferring assemblysand the hollow elongated member. According to some embodiments, thebearing may be positioned at the apex of the one or more proximal bendsand/or the one or more distal bends.

According to some embodiments, the at least two torque transferringelements may be the same or different. As a non-limiting example, thecore of the first torque transferring element may be formed from 7strands, whereas the core of the second torque transferring element maybe formed from 19 strands. As another non-limiting example, the firsttorque transferring element may include 2 outer layers, whereas thesecond torque transferring element may include 3 outer layers. Asanother non-limiting example, the first torque transferring element mayhave a different length (e.g. longer) than the second torquetransferring element.

According to some embodiments, the torque transferring assembly has hightorsional rigidity and low bending rigidity.

According some embodiments, the core of the torque transferringelement(s) is configured for maintaining high structural integrity andouter layers configured for maintaining high torsional rigidity.According some embodiments, each of the outer layers of the torquetransferring element(s) may be configured to have mechanical propertiesin a direction opposite to the direction of the adjacent layer.

According to some embodiments, the torque transferring element(s) may becapable of supporting a (optionally bi-directional) rotational speed ofat least 15,000 RPM, at least 20,000 RPM, at least 30,000 RPM, at least40,000 RPM, at least 60,000 RPM, at least 70,000 RPM, at least 80,000RPM, at least 90,000 RPM, or at least 100,000 RPM. According to someembodiments, the torque transferring element(s) may be capable ofsupporting a torque of at least 2 Ncm, at least 3 Ncm, at least 4 Ncm,at least 5 Ncm or at least 6 Ncm. Each possibility and combination ofpossibilities is a separate embodiment. As a non-limiting example,torque transferring element(s) may be capable of supporting a rotationalspeed of 80,000 RPM, at a torque of 5 Ncm.

According to some embodiments, the torque transferring element extendsfrom a motor optionally positioned within the handle of the device.According to some embodiments, the torque transferring element/assemblyis attached to the proximal end of the elongated hollow member.According to some embodiments, the torque transferring element/assemblyis attached to the rotatable cutting head and may be configured totransmit rotational (optionally bidirectional) and optionallyforward/backward motion to the rotatable cutting head.

According to some embodiments, the torque transferring element/assemblymay be configured for high torsional rigidity and low bending rigidity,potentially enabling the torque transferring element to rotate at highspeed while bent, advantageously even at a small radius of curvature.Having a low bending rigidity provides low bending-related stress andbetter resistance to fatigue caused by high rotation speed and/or highrotation torque.

According to some embodiments, the torque transferring element(s) may befabricated from stainless-steel wires (also referred to herein asstrands), twisted (braided or coiled) into a rope, constituting a core.As a non-limiting example, the torque transferring element(s) may befabricated from seven 304V stainless-steel wires (each having a diameterof, for example, 0.084 mm) twisted into a rope. Several layers e.g. 3layers, may then be wound around the rope core. Each successive layer(e.g., coil) may optionally be wound in the opposite direction of thelayer which precedes it. As a non-limiting example, the first outerlayer (the layer closest to the core) may include 5 wires (with adiameter of e.g. 0.12 mm each) coiled, stranded or twisted in a firstdirection (e.g. clockwise), the middle layer may, for example, include 5wires (with a diameter of e.g. 0.14 mm each) coiled, stranded or twistedin a direction opposite the first outer layer (e.g. counter clockwise),and the third outer layer may, for example, include 5 wires (with adiameter of e.g. 0.16 mm each) coiled, stranded or twisted in adirection opposite the middle outer layer.

According to some embodiments, the torque transferring element/assemblyhas an outer diameter of, for example, 0.3 mm to 5 mm, e.g. 0.5 mm or 1mm or 1.5 mm or 3 mm.

According to some embodiments, the torque transferring element(s) mayhave the following physical properties: bending angle: 0-90 degrees,rotation speed: 15,000-60,000 rpm, bending radius: 4.5-9 mm, diameter:0.5 mm-3 mm, and length: 5-300 mm (for example, 5-50 mm, 40-200 mm orabout 40 mm).

According to some embodiments, the torque transferring element(s) mayhave the following physical properties: bending angle: 0-90 degrees,rotation speed: 15,000-80,000 rpm, bending radius: 2-18 mm, diameter:1-7 mm, and length: 1-40 mm.

According to some embodiments, the torque transferring elements) mayhave the following physical properties: bending angle: 50-80 degrees,rotation speed: 15,000-80,000 rpm, bending radius: 6-7 mm, diameter: 3-5mm, and length: 9-30 mm.

According to some embodiments, the at least one proximal bend of thehollow member is configured to ensure visualization of the cutter and/orthe tissue adjacent to the distal end of the device, when in use.According to some embodiments, the at least one proximal bend of thehollow member is configured to ensure that the handle, the surgeon'shand, surgical microscope and/or the endoscope do not impair thevisualization of the cutter and/or the tissue adjacent to the distal endof the device, when in use. According to some embodiments, the at leastone proximal bend of the hollow member enables utilizing a surgicalmicroscope, such as a surgical microscope that has a short focal length,this since the microscope may be located parallel to the shaft and closeto the surgical site while avoiding that the handle interferes with themicroscope and the line of sight.

As used herein, the term “proximal” with referral to the elongatedhollow member refers to part of the hollow member closest to the handle.According to some embodiments, the term may refer to the ⅓ of the hollowmember closest to the handle.

As used herein, the term “distal” with referral to the elongated hollowmember refers to part of the hollow member carrying the rotatable cutterand adjacent the target tissue. According to some embodiments, thedistal end may include a tip section. According to some embodiments, thedistal end may refer to the ⅓ of the hollow member furthest away fromthe handle.

As used herein, the terms “tip” and “tip section” may refer to theengaging portion of the device, including the cutter and at least partof the distal end of the elongated hollow member. According to someembodiments, the term tip refers to the part of the elongated hollowmember (and the torque transferring element placed therein) extendingfrom the distal bend to the distal extremity thereof. According to someembodiments, the tip may have a length of 5-16 mm, for example, about 11mm. According to some embodiments, the term tip may refer to a part ofthe device configured to be inserted between bone tissue. According tosome embodiments, the tip is configured to be stationary duringoperation, at least with regards to axial rotation.

According to some embodiments, the term “at least one”, when referringto proximal bends of the hollow member, may be a single proximal bend.Alternatively, the at least one proximal bend may include 2, 3, 4, 5 ormore proximal bends. Each possibility is a separate embodiment.

According to some embodiments, the at least one proximal bend has abending angle of up to 90 degrees relative to the central axis of saidhandle. According to some embodiments, the at least one proximal bendhas a bending angle of up to 80 degrees relative to the central axis ofsaid handle. According to some embodiments, the at least one proximalbend has a betiding angle of up to 70 degrees relative to the centralaxis of said handle. According to some embodiments, the at least oneproximal bend has a bending angle of up to 60 degrees relative to thecentral axis of said handle.

According to some embodiments, the at least one proximal bend has abending angle of 10-90 degrees relative to the central axis of saidhandle. According to some embodiments, the at least one proximal bendhas a bending angle of 10-80 degrees relative to the central axis ofsaid handle. According to some embodiments, the at least one proximalbend has a bending angle of 20-80 degrees relative to the central axisof said handle. According to some embodiments, the at least one proximalbend has a bending angle of 20-60 degrees relative to the central axisof said handle.

According to some embodiments, the at least one proximal bend has abetiding radius of less than 15 mm, less than 12 mm, less than 10 mm,less that 7 mm or less than 5 mm. Each possibility is a separateembodiment. According to some embodiments, the at least one proximalbend has a bending radius in the range of 5 mm-15 mm.

According to some embodiments, the hollow member includes at least twoproximal bends. According to some embodiments, the hollow memberincludes at least three proximal bends. According to some embodiments,the hollow member includes at least four proximal bends. According tosome embodiments, the hollow member may include a plurality of proximalbends (e.g. 5 or more bends). According to some embodiments, the bendsmay be in a same plane. According to some embodiments, the bends (orsome thereof) may be in a different plane.

According to some embodiments, by being double bended, the part of thehollow member downstream to the first and second proximal bends will besubstantially parallel (e.g. +/−10 degrees) to the central axis of saidhandle. Advantageously, this may ease the maneuvering of the device bythe operator, while maintaining line of sight.

According to some embodiments, the at least two proximal bends may havea bending angle of up to 90 degrees relative to the central axis of thehandle. According to some embodiments, the at least two proximal bendsmay have a bending angle of up to 80 degrees relative to the centralaxis of the handle. According to some embodiments, the at least twoproximal bends may have a bending angle of up to 70 degrees relative tothe central axis of the handle. According to some embodiments, the atleast two proximal bends may have a bending angle of up to 60 degreesrelative to the central axis of the handle. According to someembodiments, the at least two proximal bends may have a bending angle of10-90 degrees relative to the central axis of the handle. According tosome embodiments, the at least two proximal bends may have a bendingangle of 10-80 degrees relative to the central axis of the handle.According to some embodiments, the at least two proximal bends may havea bending angle of 20-80 degrees relative to the central axis of thehandle. According to some embodiments, the at least two proximal bendsmay have a bending angle of 20-60 degrees relative to the central axisof the handle. According to some embodiments, the bending angle of theat least two proximal bends may be the same or different.

According to some embodiments, the at least two proximal bends may havea bending radius of less than 15 mm, less than 12 mm, less than 10 mm,less that 7 mm or less than 5 mm. Each possibility is a separateembodiment. According to some embodiments, the at least two proximalbends may have a bending radius in the range of 5 mm-15 mm. According tosome embodiments, the bending angle of the at least two proximal bendsmay be the same or different.

According to some embodiments, the elongated hollow member may includeat least one distal bend, such as 1, 2, 3 or more distal bends. Eachpossibility is a separate embodiment. According to some embodiments, thedistal bends may be in a same plane. According to some embodiments, thedistal bends (or some thereof) may be in a different plane. According tosome embodiments, the elongated hollow member may include a singledistal bend.

Additionally or alternatively, the device may include one or more medialbends positioned between the proximal and distal ends of the hollowelongated member, such as, but not limited to, around halfway the lengthof the hollow elongated member or between the ⅓ defining the proximalend and the ⅓ defining the distal end. According to some embodiments,the medial bends may be in a same plane. According to some embodiments,the medial bends (or some thereof) may be in a different plane.Advantageously, such medial bends may ensure an unhindered line of sitewhen utilizing the device in robotic/robot assisted surgeries.

According to some embodiment, the device may include only proximalbends, only distal bends, or only distal bends. Alternatively, thedevice may include both proximal, distal and medial bends. Eachpossibility is a separate embodiment.

According to some embodiments, the at least one distal bend may have abending angle of up to 90 degrees relative to the central axis, the partof the hollow member distal to the at least one proximal bend. Accordingto some embodiments, the at least one distal bend may have a bendingangle of up to 80 degrees relative to the part of the hollow memberdistal to the at least one proximal bend. According to some embodiments,the at least one distal bend may have a bending angle of up to 70degrees relative to the part of the hollow member distal to the at leastone proximal bend. According to some embodiments, the at least onedistal bend may have a bending angle of up to 60 degrees relative to thepart of the hollow member distal to the at least one proximal bend.According to some embodiments, the at least two proximal bends may havea bending angle of 10-90 degrees relative to the central axis of saidhandle. According to some embodiments, the at least one distal bend mayhave a bending angle of 10-80 degrees relative to the part of the hollowmember distal to the at least one proximal bend. According to someembodiments, the at least one distal bend may have a bending angle of20-80 degrees relative to the part of the hollow member distal to the atleast one proximal bend. According to some embodiments, the at least onedistal bend may have a bending angle of 20-60 degrees relative to thepart of the hollow member distal to the at least one proximal bend.According to some embodiments, the bending angle of the at least onedistal bend may be the same or different from the bending angle of theat least one proximal bend.

According to some embodiments, the at least one distal bend may have abending radius of less than 15 mm, less than 12 mm, less than 10 mm,less that 7 mm or less than 5 mm. Each possibility is a separateembodiment. According to some embodiments, the at least one distal bendmay have a bending radius in the range of 5 mm-15 mm, 2-12 mm or 6-10mm. Each possibility is a separate embodiment. As a non-limitingexample, the bending ratio may be 9 mm. According to some embodiments,the bending angle of the at least one distal bend may be the same ordifferent from the bending radius of the at least one proximal bend.

According to some embodiments, the distance between the distal bend andthe opening is less than 30 mm. According to some embodiments, thedistance between the distal bend and the opening is less than 25 mm.According to some embodiments, the distance between the distal bend andthe opening is less than 20 mm. According to some embodiments, thedistance between the distal bend and the opening is less than 15 mm.According to some embodiments, the distance between the distal bend andthe opening is less than 10 mm. According to some embodiments, thedistance between the distal bend and the opening is in the range of 1-20mm. According to some embodiments, the distance between the distal bendand the opening is in the range of 3-10 mm. As a non-limiting example,the distance between the distal bend and the opening may be 8 mm.

According to some embodiments, the distal end may be parallel to thecentral axis of the handle. As a non-limiting example, the hollow membermay include a single proximal bend and a single distal bend configuredsuch that the part of the hollow member extending between the proximaland distal bends be offset the central axis of the handle, whereas thepart of the hollow member extending from the distal bend to the distalextremity of the hollow member be parallel to the central axis of thehandle.

According to some embodiments, the distal end may be offset the centralaxis of the handle. As a non-limiting example, the hollow member mayinclude two proximal bends and a single distal bend configured such thatthe part of the hollow member extending between the proximal bends andthe distal bend be parallel to the central axis of the handle, whereasthe part of the hollow member extending from the distal bend to thedistal extremity of the hollow member be offset the central axis of thehandle.

According to some embodiments, the elongated hollow member may be, forexample, 30-300 mm, 50-200, 50-150 mm, or 75-125 mm in length, asmeasured from the handle to the distal tip. Each possibility is aseparate embodiment. As a non-limiting example, the elongated hollowmember may have a length of 104 mm.

According to some embodiments, the elongated hollow member may have acircular or oval cross section with an external diameter of, forexample, 2-10 mm, 2-5 mm, 2.5-4 mm or 3-3.5 mm. Each possibility is aseparate embodiment. As a non-limiting example, the elongated hollowmember may have an external diameter of 3.2 mm. The diameter and/orcross sectional shape of the elongated device body may be constant alongits length or may vary, for example, from a larger diameter at aproximal end to a smaller diameter at a distal end or vice versa.

According to some embodiments, the elongated hollow member may have alumen with a diameter of 1-4 mm or 2-3 mm. Each possibility is aseparate embodiment. As a non-limiting example, the elongated hollowmember may have an internal diameter of 2.8 mm. According to someembodiments, the internal lumen may be sized and shaped for intimatelyhousing a torque transferring elements/assembly, as further describedhereinbelow. According to some embodiments, the diameter of the internallumen may be 30-400% larger than the external diameter of the torquetransferring elements/assembly to ensure that at least a flexibleportion of the torque transferring elements/assembly does not kink orwarp within the lumen. According to some embodiments, the lumen may becentered within the elongated hollow member.

According to some embodiments, the elongated hollow member may befabricated from any material used in surgical devices, including, forexample, stainless-steel, cobalt chrome, Nickel Titanium alloy(Nitinol), titanium, a polymer, and the like. The various devicecomponents may be fabricated using well known approaches such asbraiding, coiling, stranding, casting, extrusion, machining, 3D printingand the like.

According to some embodiments, the rotatable cutter may include or be arotary cutting blade. According to some embodiments, the rotatablecutter may include or be a plurality of jointed cutting elements, suchas a plurality of cutting discs, and/or cutting elements such as diamondpowder.

According to some embodiments, the rotatable cutter may be cylindrical,with circumferential cutting properties. According to some embodiments,the rotatable cutter may be cylindrical, with radial circumferentialcutting properties (lateral). According to some embodiments, therotatable cutter may be cylindrical with forward/distal circumferentialcutting properties.

According to some embodiments, the rotatable cutter may be at leastpartially coated with diamonds. According to some embodiments, therotatable cutter may be at least partially embedded with blades.

According to some embodiments, the rotatable cutter may be fabricatedfrom, for example, 17.4 pH (thermal-hardened) stainless steel orstainless steel 420; for example, 2.5 mm Outer Diameter with, forexample, 2-4 spiral flutes (lead angle, for example, 26 Deg, depth, forexample, 0.75 mm, width, for example, 0.8 mm) each having a sharp edgeforming a blade. According to some embodiments, the rotatable cutter maybe in a shape of a disc comprising cutting edges at its perimeter.According to some embodiments, the rotatable cutter may include twoopposite longitudinal straight edges and two opposite lateral cuttingedges. According to some embodiments, the length of the rotatable cutterportion may vary depending on use from 1 mm-100 mm (e.g. 2 mm).

According to some embodiments, the rotatable cutter may be configured torotate axially at rotation speed of up to 100,000 rounds per minute(RPM). According to some embodiments, the rotatable cutter may beconfigured to rotate axially at a rotation speed in the range of 5,000RPM to 100,000 RPM. According to some embodiments, the rotatable cuttermay be configured to rotate axially at a rotation speed in the range of15,000 RPM to 70,000 RPM. According to some embodiments, the rotatablecutter may be configured to rotate axially at a rotation speed in therange of 20,000 RPM to 50,000 RPM.

According to some embodiments, the torque provided to the rotatablecutter may be in the range of 1-15 N*cm. According to some embodiments,the torque provided to the rotatable cutter may be in the range of 2-10N*cm. According to some embodiments, the torque provided to therotatable cutter may be in the range of 6-8 N*cm. According to someembodiments, the torque values refer to dynamic torque values,specifically at the rotation speeds of the rotatable cutter as providedin various embodiments.

According to some embodiments, the torque and/or rotation speed may becontrolled by the operator of the device/instrument.

According to some embodiments, the rotatable cutter may be configured tofacilitate at least one of: lateral cutting, posterior tissue cutting,or forward cutting. Each possibility is a separate embodiment.

According to some embodiments, the elongated hollow member may include aprotective shield. According to some embodiments, the protective shieldmay extend from the distal end of the elongated hollow member to atleast partially cover the circular action cutter and/or to at leastpartially cover the distal end of the device. According to someembodiments, the protective shield extends from the distal end of saidelongated hollow member to at least partially cover the circular actioncutter and/or to at least partially cover the distal end of the device.According to some embodiments, the protective shield may be configuredto separate between the rotatable cutter and tissue distal and below therotatable cutter, thereby mitigating the risk of impacting the tissuedue to rotation of the rotatable cutter. According to some embodiments,the protective shield may be configured to mechanically separate betweentwo tissue layers to facilitate introduction of the rotatable cutter totarget tissue. According to some embodiments, the protective shield maybe circular or semi-circular or dome shaped, with a diameter in therange of 3 mm to 10 mm. According to some embodiments, the protectiveshield may be circular or semi-circular or dome shaped, with a diameterin the range of 1 mm to 4 mm. According to some embodiments, theprotective shield may be circular or semi-circular or dome shaped, witha diameter in the range of 5 mm to 7 mm. According to some embodiments,the protective shield may be circular or semi-circular or dome shaped,with a diameter of approximately 6 mm. According to some embodiments,the protective shield is configured to shield off the distal end of therotatable cutter. According to some embodiments, the protective shieldmay be essentially perpendicular to the longitudinal axis of the distalend and/or of the circular action cutter. According to some embodiments,the protective shield may be positioned at an angle of 0-90 degrees,0-60 degrees, 10-90 degrees, 60-90 degrees or any other suitable angleor range of angles within the range of 0-90 degrees, relative to thelongitudinal axis of the distal end and/or of the circular actioncutter. According to some embodiments, the protective shield isconfigured to shield off the distal end of the rotatable cutter.According to some embodiments, the protective shield may be essentiallyperpendicular to the longitudinal axis of the distal end and/or of thecircular action cutter. According to some embodiments, the protectiveshield may be positioned at an angle of 0-90 degrees, 0-60 degrees,10-90 degrees, 60-90 degrees or any other suitable angle or range ofangles within the range of 0-90 degrees, relative to the longitudinalaxis of the distal end and/or of the circular action cutter.

According to some embodiments, the device may further include anirrigation system for irrigating the tissue while drilling/cutting,which is advantageous in preventing overheating of the target tissue orsurrounding tissues. According to some embodiments, the elongated hollowmember may include an irrigation lumen. According to some embodiments,the proximal end of the elongated hollow member may include a seal forsealing the irrigation lumen. According to some embodiments, the sealmay be composed of a temperature resistant material having a Shoredurometer value of, for example, 50 A or less. According to someembodiments, the temperature resistant material may be silicon rubber,self-lubricating silicon rubber or self-lubricating silicon rubberincluding silicon oil having a temperature independent viscosity.

According to some embodiments, the device may further include a suctionpump for removing tissue grinds and/or fluids from the cutting site.

According to some embodiments, the handle may house a drive and,optionally, a motor, as well as electrical circuitry. According to someembodiments, the housing may include an adaptor configured to allowconnection to different types of surgical motors. According to someembodiments, the handle may be configured for allowing a user tomanipulate the device and operate the motor driven rotatable cuttinghead. In that respect, the handle may be shaped substantially as aninverted cone with a length of, for example, 75-105 mm and a proximaldiameter of, for example, 20-30 mm and a distal diameter of, forexample, 5-15 mm. According to some embodiments, the handle may befabricated as a shell composed of one or more cast, machined orinjection-molded pieces. According to some embodiments, the handle mayinclude a user interface for operating the motor, setting motorparameters (for example, the rotation speed and direction of rotation,etc.), setting cutting time, operating and setting irrigation and/orsuction parameters, as well as controlling adjunct devices such as aneuro-stimulation device. According to some embodiments, the handle maybe designed and configured such that a surgeon maintains a clearline-of-site along the device, helping the surgeon to monitor progresswhile cutting some tissue and avoiding tissues not targeted for cutting.

According to some embodiments, the user interface may further include adisplay for displaying various parameters related to the motor or toirrigation, as well as information related to the cutting head andmulti-stranded wire such as temperature, mechanical integrity, cuttinghead position and the like, and information related to adjunct device(for example electrodes for neuro-monitoring) used during a procedure.

According to some embodiments, the device may be disposable in itsentirety. According to some embodiments, parts of the device aredisposable. According to some embodiments, the tip is disposable.According to some embodiments, the rotatable cutter is disposable.According to some embodiments, the torque transferring element/assemblyis disposable.

According to some embodiments, the surgical tip (at the distal end ofthe elongated hollow member, is configured to have at least twooperation modes, one of which being an insertion mode (or non-activestate), and the other being an operation/cutting mode (or active state).According to some embodiments, in the insertion mode, the rotatablecutter is positioned to not protrude out from the opening to lower therisk of impacting tissues during insertion.

According to some embodiments, the device may be connected to orconnectable to an imaging plate comprising one or more navigationelements configured to allow determining the spatial orientation and/orcoordinates of the device, when in use. According to some embodiments,the navigation elements may be made of a material allowing theirvisualization using different visualization techniques.

Reference is now made to FIG. 1A-FIG. 1C, which schematically illustratea device 100 for hard tissue removal, with a single proximal bend 150,according to some embodiments. Device 100 includes a handle 120connected to an elongated hollow member 130 having a proximal end 132and a distal end 134. Distal end 134 includes a rotatable cutting tip110 for surgical tissue cutting and a distal bend 112 configured toensure convenient positioning of rotatable cutting tip 110 into adesired target location (e.g. between adjacent vertebras or underneath avertebra). Proximal bend 150 serves to ensure that part of elongatedhollow member 130 distal to proximal bend 150 is offset of handle 120,thus ensuring a surgeon's unhindered line of site 101 to rotatablecutting tip 110, when holding handle 120. Advantageously, proximal bend150 enables utilizing surgical tools, such as, but not limited to,surgical microscopes (not shown). This since the microscope may belocated parallel to elongated hollow member 130 and close to rotatablecutting tip 110 while avoiding that handle 120 interferes with themicroscope and line of sight 101. Elongated hollowed member 130 includesa torque transferring assembly 140 extending from a motor 122, herepositioned within handle 120. Torque transferring assembly 140 isconfigured to bring about rotary motion of rotatable cutting tip 110,while maintaining a high structural integrity despite its multiple bentconfiguration.

Torque transferring assembly 140 includes rigid sections 142 a and 142 bextending along the majority of straight portions 132 a and 132 b withinelongated hollowed member 130 and bendable sections 144 a and 144 b oftorque extending along and within proximal bend 150 and distal bend 112,respectively. According to some embodiments, bendable sections 144 a and144 b extend along the entire length of proximal bend 150 and distalbend 112, respectively. According to some embodiments, bendable sections144 a and 144 b may extend along a portion longer than the length ofproximal bend 150 and distal bend 112, respectively (e.g. about 2%-5%longer than the length of proximal bend 150 and distal bend 112,respectively). According to some embodiments, bendable sections 144 aand 144 b may be separate elements, interconnected by rigid section 142b. Alternatively, torque transferring elements 144 a and 144 b may bepart of a single continuous element (not visible in its entirety)extending along the length of torque transferring assembly 140, in whichcase, rigid sections 142 a and 142 b are crimped over torquetransferring assembly 140 such that bendable sections 144 a and 144 bremain exposed. Rigid sections 142 a and 142 b are configured to ensurethat helixing of torque transferring assembly 140 isprevented/inhibited, while torque transferring elements 144 a and 144 bfacilitate high rotational speed and a torque.

According to some embodiments, handle 120 includes an operational input160 utilized, for example, for providing electric energy for operatingdevice 100, introducing additional surgical instruments, connecting tosensors, cameras, or the like.

Reference is now made to FIG. 2A-FIG. 2B, which schematically illustratea device 200 for hard tissue removal, with a single proximal bend 250,according to some embodiments. Device 200 includes a handle 220connected to an elongated hollow member 230 having a proximal end 232and a distal end 234. Distal end 234 includes a rotatable cutting tip210 for surgical tissue cutting and a distal bend 212 configured toensure convenient positioning of rotatable cutting tip 210 into adesired target location (e.g. between adjacent vertebras or underneath avertebra). Proximal bend 250 which serves to ensure that part ofelongated hollow member 230 distal to bend 250 is offset handle 220,thus ensuring a surgeon's unhindered line of site 201 to rotatablecutting tip 210, when holding handle 220. Advantageously, proximal bend250 enables utilizing surgical tools, such, as but not limited to,surgical microscopes (not shown). This since the microscope may belocated parallel to elongated hollow member 230 and close to rotatablecutting tip 210 while avoiding that handle 220 interferes with themicroscope and line of sight 201. Elongated hollow member 230 includestherein a torque transferring element/assembly (not shown).

According to some embodiments, handle 220 includes an operational input260 utilized, for example, for providing electric energy for operatingdevice 200, introducing additional surgical instruments, connecting tosensors, cameras, or the like.

Elongated hollowed member 230 includes a torque transferring assembly240 extending from a motor 222 here positioned within handle 220. Torquetransferring assembly 240 is configured to bring about rotary motion ofrotatable cutting tip 210, while maintaining high structural integritydespite the multiple bent configuration.

Torque transferring assembly 240 includes rigid sections 242 a and 242 bextending along the majority of straight portions 232 a and 232 b withinelongated hollowed member 230 and bendable section 244 a and 244 bextending along and within proximal bend 250 and distal bend 212,respectively. According to some embodiments, the bendable sections 244 aand 244 b may extend along the entire length of proximal bend 250 anddistal bend 212, respectively. According to some embodiments, bendablesections 244 a and 244 b may extend along a portion longer than thelength of proximal bend 250 and distal bend 212, respectively (e.g.about 2%-5% longer than the length of proximal bend 250 and distal bend212, respectively). According to some embodiments, bendable sections 244a and 244 b may be separate elements, interconnected by rigid section242 b. Alternatively, bendable sections 244 a and 244 b may be part of asingle continuous element (not visible in its entirety) extending alongthe length of torque transferring assembly 240, in which case, rigidsections 242 a and 242 b are crimped over or otherwise overlaying torquetransferring assembly 240 such that bendable sections 244 a and 244 bremain exposed. Rigid sections 242 a and 242 b are configured to ensurethat helixing of torque transferring assembly 240 isprevented/inhibited, while torque transferring elements 244 a and 244 bfacilitate high rotational speed and a torque.

Torque transferring assembly 240 further includes a bearing supportelement 246 positioned at apex 252 of proximal bend 250. Bearing supportelement 246 is configured to reduce friction between torque transferringassembly 240 and hollow elongated member 230 and may be any suitabletype of bearing element, such as, but not limited to, a ball bearing ora friction bearing.

Reference is now made to FIG. 3, which schematically illustrates adevice 300 for hard or soft tissue removal, with two proximal bends 350and 355, according to some embodiments. Device 300 includes a handle 320connected to an elongated hollow member 330 having a proximal end 332and a distal end 334. Distal end 334 includes a rotatable cutting tip310 for surgical tissue cutting and a distal bend 312 configured toprovide convenient positioning of rotatable cutting tip 310 at a desiredtarget location (e.g. between adjacent vertebras or underneath avertebra). Proximal bend 350 serves to ensure that elongated hollowmember 330 be offset handle 320, thus ensuring a surgeon's unhinderedline of site 301 to rotatable cutting tip 310, when holding handle 320.Proximal end 332 further includes a second proximal bend 355 configuredto facilitate that part of elongated hollow member 330 distal toproximal bend 350 be parallel to the part of elongated hollow member 330proximal to proximal bend 350. This prevents handle 320 from concealingcutting tip 310 and ensures visibility of cutting tip 310 and of targettissue during the procedure. Elongated hollow member 330 includestherein a torque transferring element, essentially similar to torquetransferring element 140 of FIG. 1A-FIG. 1C. According to someembodiments, handle 320 includes an operational input 360 utilized, forexample, for providing electric energy for operating the device,introducing additional surgical instruments, connecting to sensors,cameras, or the like.

Reference is now made to FIG. 4 which schematically illustrates a sideview of a device 400 for hard tissue removal with a hollow elongatedmember 430 extending from handle 420. Hollow member 430 includes medialbends 452, 454 and 456, positioned essentially at a middle part ofhollow elongated member 430. Advantageously, medial bends 452, 454 and456 are configured to ensure an unhindered line of site to rotatablecutting element 410, in particular when utilizing device 400 forrobotic/robot assisted surgeries. Device 400 is here shown as beingdevoid of proximal and distal bends, however configurations includingboth medial and proximal and/or distal bends are also applicable andwithin the scope of this disclosure. Similarly, hollow elongated member430 is here depicted with three medial bends; however, otherconfigurations including less or more medial bends are also envisagedand within the scope of this disclosure.

Reference is now made to FIG. 5A, which schematically illustrates adistal end 500 a of a hollow elongated member 530 a of a device fortissue removal (as disclosed herein), devoid of a distal bend, accordingto some embodiments. Due to the absence of a distal bend, tip section534 a, including rotatable cutting tip 510 a, is coextensive with hollowelongated member 530 a. Tip section 534 a further includes a shield 514a configured to shield one side of rotatable cutting tip 510 a, thusminimizing collateral damage to adjacent tissue.

Reference is now made to FIG. 5B, which schematically illustrates adistal end 500 b of a hollow elongated member 530 b of a device fortissue removal (as disclosed herein) having a distal bend 512 b. Due todistal bend 512 b, tip section 534 b, and thus rotatable cutting tip 510b, of hollow elongated member 530 b is offset the longitudinal axis ofhollow elongated member 530 b of distal end 500 b thus facilitatingaccess to difficult to access areas, such as between and underneathvertebrae. Tip section 534 b further includes a shield 514 b covering apart of rotatable cutting tip 510 b facing opposite apex 552 b of bend512 b, thus shielding tissue positioned beneath tip section 534 b.

Reference is now made to FIG. 5C, which schematically illustrates adistal end 500 c of a hollow elongated member 530 c of a device fortissue removal (as disclosed herein) having a distal bend 512 c. Due todistal bend 512 c, tip section 534 c, and thus rotatable cutting tip 510c, of hollow elongated member 530 c, is offset the longitudinal axis ofhollow elongated member 530 c of distal end 500 c, thus facilitatingaccess to difficult to access areas, such as between and underneathvertebrae. Tip section 534 c further includes a shield 514 c covering apart of rotatable cutting tip 510 c facing opposite apex 552 c of bend512 c as well as distal tip 518 c of rotatable cutting tip 510 c, thusshielding tissue positioned beneath and in front of tip section 534 c.

Reference is now made to FIG. 5D, which schematically illustrates adistal end 500 d of a hollow elongated member 530 d of a device fortissue removal (as disclosed herein) having a distal bend 512 d. Due todistal bend 512 d, tip section 534 d, and thus rotatable cutting tip 510d, of hollow elongated member 530 d, is offset the longitudinal axis ofhollow elongated member 530 d of distal end 500 d, thus facilitatingaccess to difficult to access areas, such as between and underneathvertebrae. Tip section 534 d further includes a shield 514 d covering apart of rotatable cutting tip 510 d coextensive with apex 552 d of bend512 b of rotatable cutting tip 510 d, thus shielding tissue positionedbeneath tip section 534 d.

Reference is now made to FIG. 5E, which schematically illustrates adistal end 500 e of a hollow elongated member 530 e of a device fortissue removal (as disclosed herein) having a distal bend 512 e. Due todistal bend 512 e, tip section 534 e, and thus rotatable cutting tip 510e, of hollow elongated member 530 e, is offset the longitudinal axis ofhollow elongated member 530 e of distal end 500 e, thus facilitatingaccess to difficult to access areas, such as between and underneathvertebrae. Tip section 534 e further includes a shield 514 e covering apart of rotatable cutting tip 510 e coextensive with apex 552 e of bend512 e as well as distal tip 518 e of rotatable cutting tip 510 e, thusshielding tissue positioned beneath and in front of tip section 534 e.

Reference is now made to FIG. 6, which schematically illustrates adevice for tissue removal (such as device 100 of FIG. 1A) in use forinterverbal disc tissue removal, according to some embodiments. As seenthe figure, when in the hands 690 of a surgeon, proximal bend 650 ofhollow elongated member 630 ensures that handle 620 does not interferewith the surgeon's line of site 601 towards rotatable cutting tip 610.In addition, distal bend 612 enables access to areas between andunderneath vertebra 690 of vertebrae, thus enabling removal of tissuefrom areas, which are difficult to access without distal bend 612.Advantageously, the unique torque transferring assembly disclosedherein, (such as torque transferring assembly 140 or 240, not shownhere) facilitate high speed torque delivery to rotatable cutting tip610, despite bends 650 and 612.

Reference is now made to FIG. 7A and FIG. 7B which schematicallyillustrates a device 700 for tissue removal connected to an imagingplate comprising one or more (here 4) navigation elements 782,configured to allow determining the spatial orientation and/orcoordinates of device 700, when in use. According to some embodiments,navigation elements 782 may be made of a material allowing theirvisualization using different visualization techniques.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a”, “an” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise. It willbe further understood that the terms “comprises” or “comprising,” whenused in this specification, specify the presence of stated features,integers, steps, operations, elements, or components, but do notpreclude or rule out the presence or addition of one or more otherfeatures, integers, steps, operations, elements, components, or groupsthereof.

While a number of exemplary aspects and embodiments have been discussedabove, those of skill in the art will recognize certain modifications,additions and sub-combinations thereof. It is therefore intended thatthe following appended claims and claims hereafter introduced beinterpreted to include all such modifications, additions andsub-combinations as are within their true spirit and scope.

The invention claimed is:
 1. A surgical bone cutting device, comprising:a handle configured to facilitate operation and control of said deviceby an operator; and an elongated hollow member extending from saidhandle, said hollow member comprising a proximal end and a distal end;wherein said hollow member comprises an opening at said distal endthereof, a torque transferring element/assembly, configured to be placedwithin the elongated hollow member, and a rotatable cutting elementattached to said torque transferring element/assembly and extendingthrough or positioned at said opening, and wherein said hollow membercomprises a first bend at said proximal end thereof, configured toensure that part of said hollow member distal to said proximal bend isoffset a central axis of said handle, thereby ensuring visibility ofsaid rotatable cutting element; wherein said torque transferringelement/assembly comprises a core and at least one coiled outer layerwound around the core, the core comprising a bendable multi-strandedwire, which is braided, or twisted, or interlaced or coiled and isconfigured to affect rotary motion of the rotatable cutting element; andwherein said hollow member further comprises a second proximal bendwherein said second proximal bend comprises a bending angle of 20-60degrees relative to the central axis of said handle, such that a part ofthe hollow member downstream to the first and second proximal bends issubstantially parallel to the central axis of said handle.
 2. The deviceof claim 1, wherein said first proximal bend has a bending angle of20-60 degrees relative to the central axis of said handle.
 3. The deviceof claim 1, wherein said first proximal bend has a bending radius ofless than 20 mm.
 4. The device of claim 1, wherein said second proximalbend has a bending radius of less than 20 mm.
 5. The device of claim 1,wherein said hollow member further comprises a bend at a distal endthereof, wherein a distance between said distal bend and said opening isless than 20 mm.
 6. The device of claim 5, wherein said distal bend hasa bending angle of 0-60 degrees relative to part of the hollow memberdistal to the first or second proximal bend.
 7. The device of claim 5,wherein said distal bend has a bending radius of less than 10 mmrelative to part of the hollow member distal to the first or secondproximal bend.
 8. The device of claim 1, being a surgical drill.
 9. Thedevice of claim 1, wherein said hollow member further comprises a thirdproximal bend.
 10. The device of claim 1, wherein said hollow memberfurther comprises a fourth proximal bend.
 11. The device of claim 1,wherein said torque transferring assembly further comprises a supportstructure configured to prevent helixing of said torque transferringassembly.
 12. The device of claim 11, wherein said support structurecomprises one or more rigid elements configured to define rigid andbendable sections along said torque transferring assembly/element,wherein sections of said torque transferring assembly/element, devoid ofsaid rigid elements, are bendable.
 13. The device of claim 11, whereinsaid support structure comprises one or more tubular elements crimpedover spaced apart sections of said torque transferring elongated membercoaligned with non-bend portions of said hollow elongated member. 14.The device of claim 11, wherein said support structure comprises one ormore bearings positioned along a part of the torque transferringelongated member located at bend portions of said hollow elongatedmember.
 15. A surgical bone cutting shaft, comprising: an elongatedhollow member comprising a proximal end and a distal end; wherein saidelongated hollow member comprises an opening at said distal end thereof,a torque transferring element/assembly, configured to be placed withinthe elongated hollow member, wherein said torque transferringelement/assembly comprises a core and at least one coiled outer layerwound around the core, the core comprising a bendable multi-strandedwire, which is braided, or twisted, or interlaced or coiled; and arotatable cutting element attached to said torque transferringelement/assembly and extending through or positioned at said opening,wherein said hollow member comprises a first bend at said proximal endthereof, configured to ensure that part of said hollow member distal tosaid proximal bend is offset a part of said hollow member proximal tosaid proximal bend and a second proximal bend having a bending angle of20-60 degrees relative to the central axis thereof, such that a part ofthe hollow member downstream to the first and second proximal bends issubstantially parallel to the a part of said hollow member upstream tothe first and second proximal bends, thereby ensuring visibility of saidrotatable cutting element; and wherein said torque transferringelement/assembly is configured to affect rotary motion of the rotatablecutting element.
 16. The device of claim 1, wherein said torquetransferring element/assembly is non-hollow.